Orap (pimozide)

Orap tablets contain the active ingredient pimozide, which is a type of medicine called an antipsychotic. It is sometimes described as a neuroleptic or a 'major tranquilliser', though this last term is fairly misleading, as this type of medicine is not just a tranquilliser, and any tranquillising effect is not as important as its main mechanism of action in psychiatric illness.

What is it used for?

How does it work?

Orap tablets contain the active ingredient pimozide, which is a type of medicine called an antipsychotic. It is sometimes described as a neuroleptic or a 'major tranquilliser', though this last term is fairly misleading, as this type of medicine is not just a tranquilliser, and any tranquillising effect is not as important as its main mechanism of action in psychiatric illness.

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Pimozide works by blocking dopamine receptors in the brain. Dopamine is a natural compound called a neurotransmitter, and is involved in transmitting messages between brain cells. Dopamine is a neurotransmitter known to be involved in regulating mood and behaviour, amongst other things.

Psychotic illness, and particularly schizophrenia, is thought to be caused by overactivity of dopamine in the brain. Pimozide blocks the receptors that dopamine acts on, and this prevents the overactivity of dopamine in the brain. This helps to control psychotic illness.

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Pimozide improves disturbed thoughts, hallucinations and delusions in schizophrenia and other psychotic illnesses, such as paranoid psychosis or a condition called monosymptomatic hypochondriacal psychosis. In this condition the sufferer is preoccupied with and convinced that they have one particular medical problem, for example, they may have a delusion or hallucinations that they are infected with parasites.

How do I take it?

Orap tablets can be taken either with or without food.

The dose of this medicine that is prescribed, how often to take it and how long to take it for depends on the condition being treated. It is important to follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the packet of medicine.

If you forget to take a dose take it as soon as you remember, unless it is nearly time for your next dose. In this case just leave out the forgotten dose and take the next dose as usual. Don't take a double dose to make up for a missed dose.

Unless your doctor tells you otherwise, you should not suddenly stop taking this medicine, even if you feel better and think you don't need it any more. This is because the medicine controls the symptoms of the illness but doesn't actually cure it. This means that if you suddenly stop treatment your symptoms could come back. Stopping the medicine suddenly may also rarely cause withdrawal symptoms such as nausea, vomiting, sweating, difficulty sleeping, or abnormal involuntary muscle movements. When treatment with this medicine is stopped, it should be done gradually, following the instructions given by your doctor.

Warning!

This medicine may cause drowsiness and blurred vision. If affected do not drive or operate machinery. You should avoid drinking alcohol while taking this medicine because it can make drowsiness worse.

The manufacturer recommends that you should avoid drinking grapefruit juice or eating grapefruit while taking this medicine, as grapefruit can affect the level of the medicine in your body and could increase the risk of side effects.

Your heart function should be checked with an electrocardiogram (ECG) before you start treatment with this medicine. This test should be repeated every year to monitor your heart and make sure this medicine is not affecting it.

It is recommended that you have regular blood tests to monitor the levels of electrolytes (salts such as potassium and magnesium) in your blood while you are taking this medicine.

Antipsychotic medicines can sometimes affect the ability of the body to control its core body temperature. This is more likely to be a problem in elderly people and can result in heat stroke in hot temperatures and hypothermia in cold temperatures. It is important to avoid situations that can result in you overheating or getting dehydrated. Ask your doctor or pharmacist for more advice.

Consult your doctor immediately if you experience abnormal movements, particularly of the face, lips, jaw and tongue, while taking this medicine. These symptoms may be indicative of a rare side effect known as tardive dyskinesia, and your doctor may ask you to stop taking this medicine, or decrease your dose.

Consult your doctor immediately if you experience the following symptoms while taking this medicine: high fever, sweating, muscle stiffness, faster breathing and drowsiness or sleepiness. These symptoms may be due to a rare side effect known as the neuroleptic malignant syndrome, and your treatment may need to be stopped.

Antipsychotic medicines are associated with an increased risk of getting a blood clot in a vein (deep vein thrombosis) or in the lungs (pulmonary embolism). For this reason, you should consult a doctor immediately if you get any of the following symptoms, as these could suggest you have a blood clot: stabbing pains and/or unusual redness or swelling in one leg, pain on breathing or coughing, coughing up blood or sudden breathlessness.

Use with caution in

Elderly people with dementia. (Antipsychotic medicines have been shown to increase the risk of stroke in this group of patients. Pimozide is not licensed or recommended for treating behavioural disturbances in elderly people with dementia).

People with other risk factors for getting a blood clot, for example smoking, being overweight, taking the contraceptive pill, being over 40, recent major surgery or being immobile for prolonged periods.

People with severely reduced awareness, slow reactions or drowsiness, eg due to medicines or illness that reduce activity in the brain and nervous system.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine during pregnancy has not been established. It should not normally be used in pregnancy, particularly in the first and third trimesters, unless considered essential by your doctor. If the medicine is used during the third trimester it could cause side effects or withdrawal symptoms in the baby after birth and the baby may need extra monitoring because of this. If you are concerned or want any further information you should talk to your doctor or pharmacist.

If you do get pregnant while taking this medicine it is important to consult your doctor straight away for advice. If you have been taking the medicine for long periods of time, for instance to treat schizophrenia, you should not suddenly stop taking it unless your doctor tells you to, as this could cause your symptoms to come back.

This medicine passes into breast milk and may potentially have adverse effects on a nursing infant. The manufacturer states that mothers who need to take this medicine should not breastfeed. Ask your doctor for further information and advice.

Label warnings

This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

Other medicines that may be associated with an abnormal heart rhythm (prolonged QT interval on the heart monitoring trace or ECG) should not be taken in combination with pimozide. These include the following:

SSRI antidepressants such as sertraline, paroxetine, citalopram or escitalopram

telaprevir.

If this medicine is taken in combination with medicines that can disturb the normal levels of electrolytes (salts, such as potassium and sodium) in your blood, there may be an increased risk of side effects on the heart. These types of medicines, for example diuretics such as bendroflumethiazide or furosemide, are not recommended for use with pimozide. If you need treatment with a diuretic, a potassium-sparing diuretic such as spironolactone is preferred.

There may be an increased risk of drowsiness and sedation if any of the following (which can also cause drowsiness) are taken with pimozide:

alcohol

barbiturates, eg amobarbital, phenobarbital

benzodiazepines, eg diazepam, temazepam

MAOI antidepressants, eg phenelzine

sedating antihistamines, eg chlorphenamine, hydroxyzine

sleeping tablets, eg zopiclone

strong opioid painkillers, eg morphine, codeine

tricyclic antidepressants, eg amitriptyline.

This medicine may enhance the blood pressure-lowering effects of certain medicines used to treat high blood pressure (antihypertensives). If you are taking medicines for high blood pressure you should tell your doctor if you feel dizzy or faint after starting treatment with this medicine, as your blood pressure medicines may need adjusting.

There may be an increased risk of extrapyramidal-type side effects (abnormal body movements) if this medicine is used in combination with lithium, metoclopramide or tetrabenazine.

Pimozide may oppose the effect of anticonvulsant medicines used to treat epilepsy.

Pimozide may oppose the effect of levodopa and medicines for Parkinson's disease that work by stimulating dopamine receptors in the brain, for example ropinirole, pergolide, bromocriptine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain pimozide as the active ingredient.

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